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A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain

Pain Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Moderate to Severe Knee or Hip Pain From Osteoarthritis

Clinical Trial Summary

The purpose of this study is to compare the safety and effectiveness of different doses of JNJ-42160443 with placebo in the treatment of chronic, moderate to severe knee or hip pain in patients with a diagnosis of osteoarthritis.

Clinical Trial Description

This current study is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the safety and effectiveness of different doses of JNJ-42160443 compared with placebo in the treatment of patients with a diagnosis of osteoarthritis of the hip or the knee who have moderate to severe pain that is not controlled by standard pain medications.Osteoarthritis is a chronic disease that affects the joints, and is characterized by degeneration of cartilage and bone. The duration of the study is approximately 133 weeks (3-week screening phase, 12-week double-blind efficacy phase, 92-week double-blind extension phase, and 26-week post treatment phase).JNJ-42160443 (10 mg/mL) or matching placebo given as an subcutaneous (injection under the skin) (SC) once every 4 weeks will be administered in the study as 1 of 5 JNJ-42160443 dosages:1 mg every 4 weeks, 3 mg every 4 weeks, 3 mg every 8 weeks, 6 mg every 8 weeks; or 10 mg every 8 weeks, or matching placebo for up to approximately 104 weeks (12-week double-blind efficacy phase + 92-week double-blind extension phase). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00973141
Study type Interventional
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status Terminated
Phase Phase 2
Start date September 16, 2009
Completion date June 30, 2011
View Details
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